Elmiron, also known as pentosan polysulfate sodium, is a prescription drug used to treat and manage bladder pain caused by interstitial cystitis. But medical evidence suggests that this medication can potentially cause an ocular disorder known as maculopathy. The condition affects the macula, a fundamental part of the retina. Although maculopathy’s initial signs include blurred vision, blind spots, and trouble reading, it can also cause total vision loss.
If you’ve developed eye damage or total vision loss after using this prescription medication, you might be eligible to join a mass tort litigation against Janssen Pharmaceuticals, the Elmiron manufacturer. Taking legal action can help you recover financial compensation and hold Janssen Pharmaceuticals accountable for their negligence.
What Is Elmiron and What Is It Prescribed For?
Elmiron is a prescription drug made by Janssen Pharmaceuticals, a Johnson and Johnson subsidiary. It treats patients with interstitial cystitis. The Food and Drug Administration (FDA) approved it in 1996 for the treatment and management of bladder pain syndrome (BPS) or discomfort related to interstitial cystitis (IC).
Health professionals, including urogynecologists and urologists, often prescribe Elmiron to treat and manage the pain and discomfort caused by interstitial cystitis when dietary changes offer no relief. Interstitial cystitis causes various symptoms, such as bladder discomfort and pain that intensifies as the bladder fills, pain when urinating, frequent urination, and urinary urgency.
While Elmiron isn’t a pain reliever, it might work by forming a barrier against acidic urine that may irritate the already damaged bladder lining.
It’s vital to note that this medication doesn’t cure interstitial cystitis but treats many bothersome signs of the chronic condition. You might return to normal activities with time because your bladder functions become more manageable.
In 2020, Janssen Pharmaceuticals added a new warning to the drug’s label. The new warning noted that Elmiron could potentially cause retinal pigmentation changes. Signs of this retinal problem include inability to see clearly, difficulty reading, and difficulty adjusting to dim lights. There have been no recalls for the prescription drug; however, more medical studies are being reviewed. Although the FDA hasn’t recalled Elmiron, they’re expected to continue assessing the situation.
Elmiron’s Link to Vision Problems and Eye Damage
A medication prescribed for bladder problems for many years has now been linked to retinal damage. The retina is the light-sensing tissue behind the eye that enables you to see. After the initial report in 2018 that Elmiron might be linked with vision problems, three ophthalmologists reviewed patients of Kaiser Permanente in Oakland, California. They found that nearly 25% of patients with substantial exposure to the drug showed definite symptoms of retinal damage, and that Elmiron toxicity can masquerade as other eye problems, including pattern dystrophy or age-related macular degeneration.
IC causes chronic discomfort and pain in the pelvis and bladder. Over 1 million people in the U.S., mainly women, may have this chronic condition. The FDA has only approved Elmiron to treat this condition. And as the mainstay treatment for years, it means hundreds of thousands of patients have likely been exposed to this medication.
In 2018, eye specialists at Emory Center in Georgia reported six patients who had been using the medication for nearly 15 years had developed unusual macula changes. The macula is the main part of the retina that delivers clear, crisp, and central vision. As nothing in the patients’ diagnostic tests or medical history explained the unusual pattern of abnormalities, Dr. Nieraj Jain and his colleagues warned that long-term Elmiron use could damage the retina.
Emory researchers also found that long-term Elmiron use affects the development of retinal problems. Using the medication for 7 years also significantly increased the odds of developing pigmentary maculopathy (changes to the retina), compared to 5 years of usage.
In addition, pentosan polysulfate sodium, especially after long-term use at high dosages, has been linked to incidents of pigmentary maculopathy resulting in eye damage. Thus, it’s imperative for patients taking this drug to undergo frequent ophthalmic examinations and seek immediate medical help in case they experience any visual changes.
Although studies are still being done on the potential link between Elmiron toxicity, interstitial cystitis, the bladder, and eye damage, four doctors recently wrote in Retina Today that substantial evidence links chronic exposure to Elmiron with the development of pigmentary maculopathy.
Here are more scientific studies linking Elmiron use to eye damage:
- A case study by Tapan P Patel, Kapil Mishra, and Mandeep S Singh details the development of pathological blood vessels in the eye, causing vision loss in patients using Elmiron long term.
- A medical journal by Rui Chen, William A Perce, and Nierjah Jain, correlates long-term use of pentosan polysulfate sodium with a form of macular degeneration called pigmentary maculopathy. The scientific study found medication-induced retinal damage in 24% of patients, which seemed to be dosage-related.
- A 2020 cross-sectional study reported a 20% prevalence of Elmiron-induced maculopathy in the participants tested.
These scientific studies recommend that patients taking the drug or those who have used it in the past undergo an eye examination by an experienced ophthalmologist. Patients with no signs of Elmiron toxicity should also be examined for eye damage at least once a year.
Types of Vision Issues Associated with Elmiron Use
Pentosan polysulfate sodium, a prescription drug for interstitial cystitis, is linked to vision problems, including:
- Pigmentary maculopathy (damage to the back of the retina)
- Difficulty reading
- Blurred vision
- Central vision loss
- Distorted vision
- Colors seeming less vivid or dull
- Trouble adjusting to dull lighting
- Difficulty recognizing faces
- Blind spots (scotoma)
- Eye color change
- Glare
- Spots or floaters in the field of vision
- Straight lines appear wavy or curvy (metamorphopsia)
- Night vision problems
- Difficulty seeing close objects
- Blindness
If you have experienced any of the above health complications after using Elmiron, contact your doctor as soon as possible. After seeking medical help, contact an experienced product liability lawyer at once. An attorney skilled in mass tort litigation can help you recover monetary compensation for your medical expenses and other costs associated with your treatment.
Current Status of Elmiron Mass Tort Litigation
Medical studies have linked Elmiron use to an elevated risk of vision problems. Patients who were prescribed the drug and developed pigmentary maculopathy have accused Janssen Pharmaceuticals, the Elmiron manufacturer, of not adequately warning the public about the possible risks of ocular toxicity and potential permanent eye damage or total vision loss.
Most patients were initially misdiagnosed, blaming their eye damage and vision loss on other factors.
It’s only with recent research that reported eye damage has been linked to Elmiron.
Most Elmiron lawsuits have been merged into the Elmiron multidistrict litigation (MDL) in the New Jersey Federal Court. Elmiron multidistrict litigation (2973) was created in 2022.
There are 1,900 cases pending in a federal multidistrict litigation as of March 2025 before Judge Brian Martinotti. Some Elmiron maculopathy claims were confidentially settled in 2023. A total of 1,986 plaintiffs have filed Elmiron lawsuits in the MDL No. 2973. Monetary settlements are expected in the Elmiron multidistrict litigation.
The Elmiron mass tort litigation is ending, and lawsuits could settle soon.
Latest Updates on Elmiron Settlements and Trials
Janssen Pharmaceuticals and Johnson & Johnson began settling Elmiron maculopathy claims in 2023; however, they haven’t publicly disclosed the official settlement amounts.
Some product liability attorneys estimate Elmiron lawsuit settlement amounts might be in the tune of hundreds of thousands of dollars.
However, since there have been no court trials, global Elmiron settlement offers, or jury verdicts, determining accurate Elmiron lawsuit settlement amounts is daunting. Bellwether trial verdicts often act as a benchmark for the value of these lawsuits.
The first Elmiron bellwether trial was set for March 2023. But it was later canceled and never rescheduled, as lawyers continue to work on a possible global settlement.
Potential Compensation in Elmiron Lawsuits
There are 1,273 pending lawsuits in the MDL against Janssen Pharmaceuticals, though legal experts say Bellwether trials might currently be in settlement discussions. However, no formal settlement amounts have been announced for MDL 2973 yet.
Attorneys predict MDL 2973 will result in a settlement. Structured payouts will certainly depend on different injury tiers, with each complainant receiving set financial compensation based on their sustained damages. The degree of eye damage the complainant suffered will likely be a fundamental factor in determining Elmiron lawsuit compensation. Complainants might seek monetary compensation for both economic and non-economic damages.
Damages that may be considered in compensation include:
- Past and future medical bills
- Lost income
- Reduced earning capacity
- Loss of consortium
- Reduced quality of life
- Pain and suffering
- Punitive damages
State laws and regulations could also influence compensation amounts. The availability and strengths of medical evidence and the expected outcome of bellwether trials will also play key roles.
Who Qualifies to File an Elmiron Lawsuit?
If you were prescribed Pentosan polysulfate sodium and developed pigmentary maculopathy, retinal injury, reduced vision, and other adverse eye complications, you may be eligible to file an Elmiron lawsuit.
Further, if you took this medication for at least two years and were diagnosed with eye complications, like pigmentary maculopathy or total vision loss, you might be eligible for financial compensation for any economic and non-economic damages you incurred due to your injuries.
A qualified Elmiron vision damage lawyer can help you determine your total damages, inclusive of compensatory and punitive damages.
FDA Warnings About Elmiron’s Vision Risks
While multiple scientific studies and medical literature have linked Elmiron use to maculopathy and other eye problems, the FDA hasn’t recalled the medication yet. The medication was created to treat and manage IC, a debilitating bladder condition. Currently, there are no Elmiron generic versions or alternatives, which may explain why the FDA is hesitant to recall it.
However, in response to the reported cases of vision problems linked to this drug, the FDA approved changes to the medication’s label in June 2020, warning about the risks of pigmentary maculopathy among people who had been using this drug for extended periods of time. But complainants and their attorneys claim that Janssen Pharmaceuticals knew about potential eye damage problems long before the 2020 warning and should have issued an earlier warning.
The FDA warning has likely saved many people from vision loss. However, it should have included the fact that eye problems could develop even after a patient stops using the medication. This means that people who have used the medication in the past should schedule frequent eye examinations with their doctor and educate themselves on the symptoms of retinal complications.
How to File an Elmiron Lawsuit
To file an Elmiron vision damage lawsuit, you must seek medical assessment for eye damage after Elmiron use, collect relevant medical documents, and consult with a product liability attorney familiar with such lawsuits.
Here’s a comprehensive step by step guide:
- Seek medical assessment. If you’ve used this drug to treat IC and have developed vision complications, it’s imperative to schedule an eye exam with your eye doctor to diagnose any potential eye problems.
- Collect relevant medical documents. Gather all relevant medical documentation, including doctor’s notes, prescriptions, pharmacy receipts, symptoms journal, and any other documents related to your eye damage after Elmiron use.
- Consult with an experienced Elmiron lawsuit lawyer. Contact an attorney familiar With Elmiron maculopathy claims to discuss your eligibility criteria and your legal options.
- Consider joining a mass tort litigation against Janssen Pharmaceuticals. Mast tort litigations allow parties injured by the same company or product to file a claim together against the negligent party. This type of litigation differs from class action lawsuits, which treat all plaintiffs as one entity, in that mass torts litigate each claimant’s case separately, ensuring fair compensation. You can join an Elmiron mass tort litigation no matter your location.
Choosing an Attorney for Your Elmiron Case
To find the best Elmiron vision damage attorney for your lawsuit, you must look for an attorney who can offer you:
- A proven track record. Has the Elmiron maculopathy attorney had success with similar lawsuits? Working with an attorney has successfully represented claimants who developed eye problems after using Elmiron can improve your odds of receiving compensation.
- Free case evaluations. Look for an Elmiron attorney who offers a free, no-obligation legal consultation on your claim.
- Extensive experience. Choose an attorney that has been around for many years and has the experience required to fight for your rights.
- Contingency basis fee structure. Working with an Elmiron lawyer who works on a contingency basis means there will be no upfront fees. They will only get paid if you get compensated. This motivates your attorney to fight for you because they won’t get paid unless they win your case.
What Did Elmiron Vision Damage Lawsuits Claim?
Patients who suffered vision complications, including maculopathy, filed Elmiron lawsuits against Janssen pharmaceuticals.
They allege this drug profoundly changed their lives. They were using a prescription drug they thought would improve their bladder problems. But now, they can’t enjoy normal life activities, like reading a book–because they’ve developed maculopathy and other vision-related complications.
These plaintiffs claim that Elmiron, a drug used to treat and manage IC, has damaged their eyes and that it’s a highly defective medication. Also, they allege that Janssen Pharmaceuticals withheld adverse side effects reports from the public, the FDA, and the medical community.
The complainants call for Janssen Pharmaceuticals to compensate them for irreversible eye problems.
Contact a Skilled Elmiron Defective Product Attorney Today!
Maculopathy and other vision complications can adversely affect your life, making daily tasks extremely difficult and causing medical expenses to pile up. If you’ve developed Elmiron-induced vision complications, you deserve to recover adequate compensation to cover your medical bills, pain and suffering, and financial loss.
Although it’s still not clear if Janssen will be held accountable for its failure to warn the public about Elmiron’s adverse side effects, working with a skilled product liability attorney can help you receive the compensation you deserve. At AllConsumer.com, we advocate for your right to safety and open information. Sign up today for up-to-date information on the products you’re consuming.
